Metastatic Pancreatic CancerPhase 2GECANCT01303029
Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine+erlotinib and Gemcitabine+erlotinib+capecitabine in people with Metastatic Pancreatic Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
The purpose of the study is to evaluate the efficacy of the combination of gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Gemcitabine+erlotinib and Gemcitabine+erlotinib+capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2011to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign a written informed consent
- Able, in the investigator's opinion, to fulfill the procedures and explorations of the study
- Age ≥ 18 years old
- ECOG 0-2
- Life expectancy ≥ 12 weeks
- Patients with metastatic adenocarcinoma of the pancreas, following 7th edition of TNM classification
Show all 21Show fewer
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
- Measurable disease following RECIST criteria version 1.1
- No previous systemic treatment for metastatic pancreatic cancer Adjuvant chemotherapy al least 6 months before enrollment is allowed. Patients having neoadjuvant chemotherapy must have completed the treatment at least 4 weeks before trial entry. Toxicities associated to previous treatment must be resolved before enrollment. Progression disease (metastatic disease) must be confirmed after adjuvant treatment
- Adequate bone marrow function as determined by:
- Hemoglobin: ≥ 9 g/dL. (patients with hemoglobin < 9 g/dL could be transfused before their inclusion on the study)
- Platelets: ≥ 100 x 109/L
- Absolute Neutrophil account (ANC) ≥ 1,5 x 109/L
- Adequate liver function, as determined by:
- Serum bilirubin ≤ 1,5 x LSN
- AST, ALT ≤ 2,5 x LSN in patients without liver metastasis. In patients with liver metastasis ≤ 5 x LSN
- Alkaline phosphatase ≤ 2,5 x LSN or ≤ 5 x LSN in patients with liver metastasis. In patients with bone metastasis ≤ 10 x LSN
- Adequate renal function, as determined by:
- Creatinine clearance using the Cockcroft-Gault formula ≥ 50.0 ml/min
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to randomization. Postmenopausal women are defined as those who have been amenorrheic for at least 12 months. Also, both men and women enrolled in this study must use adequate birth control (eg., abstinence, intrauterine device, oral contraceptive or double barrier method or be surgically sterile), starting at the signing of the informed consent and up to at least 6 months after completion of treatment or the last dose, whichever occurs first
- Patients must not have undergone a major surgical procedure within 4 weeks prior to study treatment. The surgical wound should be completely healed
Who cannot join
- Local pancreatic cancer (stage IA-IIB) or locally advance cancer (stage III), following the TNM 7th edition classification. Patients with metastatic disease that relapse after the initial diagnosis of local or advance disease could be included in this study
- Pancreatic endocrine tumor and ampulloma
- Evidence of carcinomatosis meningitis or brain metastasis. In case of clinical suspicious of brain metastasis is mandatory to perform a brain TAC/MR 4 weeks prior de inclusion.
- Primary tumors developed 5 years previous to the inclusion, except in situ cervix carcinoma or skin basocellular cancer properly treated
- Cardiovascular disease clinically significant (active):
- Non-controlled arterial hypertension (Systolic pressure > 150 mg Hg and/or diastolic pressure > 100 mm Hg on repeated pressure measurements)
Show all 23Show fewer
- Cerebrovascular accident/ictus (≤ 6 weeks prior to inclusion)
- Myocardial infarction (≤ 6 months prior to inclusion)
- Unstable angina
- Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)
- Severe cardiac arrythmia requiring treatment
- Significant ophthalmologic anomalies
- Deficit in Dihydropyrimidine-Dehydrogenase (DPD)
- Unable to take oral drug. Previous surgical process that affect the absorption or make the needed to have intravenous feeding or parenteral nutrition with lipids
- Pregnancy women or in lactation period
- Antineoplastic treatment (chemotherapy, hormonal treatment, radiotherapy, surgery, biological therapy or tumor embolization) 4 weeks prior the inclusion
- Previous treatment with capecitabine or EGFR inhibitor
- Metabolic disease or any other disease which, in the investigator's opinion, might interfere with the treatment in study
- Known hypersensibility to any study drug (gemcitabine, erlotinib, capecitabine) or to 5-fluorouracile and fluoropyrimidines
- Current infection grade ≥ 2 (CTCAE)
- Known human immunodeficiency virus infection, or chronic infection with hepatitis B or C virus, or severe uncontrolled intercurrent infection or other severe uncontrolled concomitant diseases
- Medical, psychological, psychiatric or sociological conditions that would interfere to the patient participation in the study or in the assessment of the results
- Current or 30 days previous to study treatment with other investigational drug or participation in other trial
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Cooperative Group for Digestive Tumour Therapy
Madrid, 28046
About this study
Official title: A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer
The purpose of the study is to evaluate the efficacy of the combination of gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic pancreatic cancer.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Gemcitabine+erlotinib, Gemcitabine+erlotinib+capecitabine
- Keywords
- Pancreatic cancer, gemcitabine, erlotinib, capecitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine+erlotinibDrug
Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks .
Gemcitabine+erlotinib+capecitabineDrug
Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Capecitabine will be administered orally 1.660 mg/m2 day from day 1 to day 21. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks .
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Gemcitabine+erlotinib Receives: Drug: Gemcitabine+erlotinib |
| Experimental | Experimental | Gemcitabine+erlotinib+capecitabine Receives: Drug: Gemcitabine+erlotinib+capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 4 years
Secondary outcomes (5)
Overall survival
Measured: 4 years
Response rate (RR)
Measured: 4 years
Duration of response
Measured: 4 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 4 years
Percentage of rash in patients treated with erlotinib and progression free survival and overall survival and treatment relationship
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Antonio Irigoyen, MD, Study chair, Hospital de Toledo, SpainManuel Benavides, MD, Study chair, Hospital Carlos Haya, Málaga. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303029
- Sponsor's protocol ID
- TTD-10-01
- Other IDs
- 2010-022599-30
- Acronym
- GECA
- Status last verified
- Jul 2017
- First submitted
- 16 Feb 2011
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Irigoyen A, Gallego J, Guillen Ponce C, Vera R, Iranzo V, Ales I, Arevalo S, Pisa A, Martin M, Salud A, Falco E, Saenz A, Manzano Mozo JL, Pulido G, Martinez Galan J, Pazo-Cid R, Rivera F, Garcia Garcia T, Serra O, Fernandez Parra EM, Hurtado A, Gomez Reina MJ, Lopez Gomez LJ, Martinez Ortega E, Benavides M, Aranda E; Spanish Cooperative Group of Treatment of Digestive Tumors (TTD). Gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in the first-line treatment of patients with metastatic pancreatic cancer: Efficacy and safety results of a phase IIb randomised study from the Spanish TTD Collaborative Group. Eur J Cancer. 2017 Apr;75:73-82. doi: 10.1016/j.ejca.2016.12.032. Epub 2017 Mar 7.
PubMed 28222309
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01303029
- Acronym / sponsor ID
- GECA / TTD-10-01
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Pancreatic cancer, gemcitabine, erlotinib, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Feb 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy of the combination of gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Gemcitabine+erlotinibGemcitabine+erlotinib |
| Experimental | Experimental | Drug: Gemcitabine+erlotinib+capecitabineGemcitabine+erlotinib+capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Ability to understand and willingness to sign a written informed consent
- Able, in the investigator's opinion, to fulfill the procedures and explorations of the study
- Age ≥ 18 years old
- ECOG 0-2
- Life expectancy ≥ 12 weeks
Key exclusion criteria (23 listed)
- Local pancreatic cancer (stage IA-IIB) or locally advance cancer (stage III), following the TNM 7th edition classification. Patients with metastatic disease that relapse after the initial diagnosis of local or advance disease could be included in this study
- Pancreatic endocrine tumor and ampulloma
- Evidence of carcinomatosis meningitis or brain metastasis. In case of clinical suspicious of brain metastasis is mandatory to perform a brain TAC/MR 4 weeks prior de inclusion.
- Primary tumors developed 5 years previous to the inclusion, except in situ cervix carcinoma or skin basocellular cancer properly treated
- Cardiovascular disease clinically significant (active):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine+erlotinibGemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks . | Drug | Control |
| Gemcitabine+erlotinib+capecitabineGemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Capecitabine will be administered orally 1.660 mg/m2 day from day 1 to day 21. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks . | Drug | Experimental |
Primary outcome
Progression free survival
Time frame: 4 years
5 secondary outcomes
Overall survival
Time frame: 4 years
Response rate (RR)
Time frame: 4 years
Duration of response
Time frame: 4 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 4 years
Percentage of rash in patients treated with erlotinib and progression free survival and overall survival and treatment relationship
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 28222309Irigoyen A, Gallego J, Guillen Ponce C, Vera R, Iranzo V, Ales I, Arevalo S, Pisa A, Martin M, Salud A, Falco E, Saenz A, Manzano Mozo JL, Pulido G, Martinez Galan J, Pazo-Cid R, Rivera F, Garcia Garcia T, Serra O, Fernandez Parra EM, Hurtado A, Gomez Reina MJ, Lopez Gomez LJ, Martinez Ortega E, Benavides M, Aranda E; Spanish Cooperative Group of Treatment of Digestive Tumors (TTD). Gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in the first-line treatment of patients with metastatic pancreatic cancer: Efficacy and safety results of a phase IIb randomised study from the Spanish TTD Collaborative Group. Eur J Cancer. 2017 Apr;75:73-82. doi: 10.1016/j.ejca.2016.12.032. Epub 2017 Mar 7.
- Related InfoLink provided by the sponsor.
Related trials for Metastatic Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Irigoyen, MD study chair
Hospital de Toledo, Spain
Manuel Benavides, MD study chair
Hospital Carlos Haya, Málaga. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine+erlotinib and Gemcitabine+erlotinib+capecitabine in people with Metastatic Pancreatic Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01303029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.